Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT07110402
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2025-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Treatment of Osteoarthritis of the Knee in the Form of Chondromalacia of the Articular Cartilage Treated in the Arthroscopic Technique With the Use of:Autogenous Transplantation of Fragmented Adipose Tissue,PRP GF,Mesenchymal Cells,Hyaluronic Acid-low Molecular Weight and Cross-linked
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D002357', 'term': 'Cartilage Diseases'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1. Autogenous transplant of fragmented adipose tissue taken from abdominal integuments - (MyStem, Lipogems, Arthrex)\n2. PRP GF (platelet-rich plasma with growth factors) (Ycellbio, ACP Arthrex, Neoregen, FrankPharma)\n3. Mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest - (Harvest, Arthrex)\n4. Hyaluronic acid - low molecular weight (Synvisc, Biolevox, ArtiAidPlus)\n5. Hyaluronic acid - cross-linked Arti Aid Plus, Synovial, Durolain, StavOn, Collagenu - Guna, Orthokine.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-08-05', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tegner Activity Level Scale (TAS)', 'timeFrame': '1 day', 'description': 'The Tegner Activity Scale (TAS) aims to provide a standardized method in determining the level of activity prior to injury and level of activity post injury that can be documented on a numerical scale.\n\nThe Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.'}, {'measure': 'Tegner Activity Level Scale (TAS)', 'timeFrame': '3 months after procedure', 'description': 'The Tegner Activity Scale (TAS) aims to provide a standardized method in determining the level of activity prior to injury and level of activity post injury that can be documented on a numerical scale.\n\nThe Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.'}, {'measure': 'Tegner Activity Level Scale (TAS)', 'timeFrame': '6 months after procedure', 'description': 'The Tegner Activity Scale (TAS) aims to provide a standardized method in determining the level of activity prior to injury and level of activity post injury that can be documented on a numerical scale.\n\nThe Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.'}, {'measure': 'Visual Analogue Score (VAS)', 'timeFrame': '1 day', 'description': 'In this method, the examined person marks a point on a line with a length of (for example) 10 cm, where the value 0 is assigned to the complete absence of pain, and the value 10 to the strongest pain imaginable.'}, {'measure': 'Visual Analogue Score (VAS)', 'timeFrame': '3 months after procedure', 'description': 'In this method, the examined person marks a point on a line with a length of (for example) 10 cm, where the value 0 is assigned to the complete absence of pain, and the value 10 to the strongest pain imaginable.'}, {'measure': 'Visual Analogue Score (VAS)', 'timeFrame': '6 months after procedure', 'description': 'In this method, the examined person marks a point on a line with a length of (for example) 10 cm, where the value 0 is assigned to the complete absence of pain, and the value 10 to the strongest pain imaginable.'}, {'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': '1 day', 'description': 'The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is defined as a disease-specific instrument used for assessing quality of life, particularly focusing on activity limitation in individuals with osteoarthritis.\n\nThe WOMAC consists of three subscales and has a total possible score range of 0 to 96: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points.\n\nLower scores indicate better health status (less pain, stiffness, and functional limitations), while higher scores represent worse outcomes ( worse pain, stiffness, and functional limitations).'}, {'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': '3 months after procedure', 'description': 'The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is defined as a disease-specific instrument used for assessing quality of life, particularly focusing on activity limitation in individuals with osteoarthritis. The WOMAC consists of three subscales and has a total possible score range of 0 to 96: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Lower scores indicate better health status (less pain, stiffness, and functional limitations), while higher scores represent worse outcomes ( worse pain, stiffness, and functional limitations).'}, {'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': '6 months after procedure', 'description': 'The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is defined as a disease-specific instrument used for assessing quality of life, particularly focusing on activity limitation in individuals with osteoarthritis. The WOMAC consists of three subscales and has a total possible score range of 0 to 96: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Lower scores indicate better health status (less pain, stiffness, and functional limitations), while higher scores represent worse outcomes ( worse pain, stiffness, and functional limitations).'}, {'measure': 'IKDC SUBJECTIVE KNEE EVALUATION FORM', 'timeFrame': '1 day', 'description': 'Interpreted as a measure of function, such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with sporting activities or daily living and the complete absence of symptoms.'}, {'measure': 'IKDC SUBJECTIVE KNEE EVALUATION FORM', 'timeFrame': '3 months after procedure', 'description': 'Interpreted as a measure of function, such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with sporting activities or daily living and the complete absence of symptoms.'}, {'measure': 'IKDC SUBJECTIVE KNEE EVALUATION FORM', 'timeFrame': '6 months after procedure', 'description': 'Interpreted as a measure of function, such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with sporting activities or daily living and the complete absence of symptoms.'}, {'measure': 'Biomechanical examination', 'timeFrame': '3 months after procedure', 'description': 'On the Biodex 3 System measuring device'}, {'measure': 'Biomechanical examination', 'timeFrame': '6 months after procedure', 'description': 'On the Biodex 3 System measuring device'}, {'measure': 'Magnetic resonance imaging (MRI) of the knee joint', 'timeFrame': '6 months after procedure', 'description': 'MRI (1.5 Tesli) will be used to assess the cartilage healing process following arthroscopic surgery. Radiological assessment will include cartilage defect fill, tissue integration, surface smoothness, and signal intensity of repair tissue.\n\nAn imaging appearance indicative of effective healing is interpreted as a better outcome.'}, {'measure': 'Ultrasound examination (USG) of the knee joint', 'timeFrame': '6 months after procedure', 'description': "Ultrasound examination on the apparatus with the option of elastometry will be used to assess postoperative tissue regeneration and intra-articular conditions. USG will be performed using a linear transducer with a frequency of 7-10 MHz. The evaluation will include: cartilage surface regularity and thickness, presence or absence of joint effusion, synovial membrane hypertrophy (synovitis), swelling or inflammatory changes in Hoffa's fat pad, signs of active inflammation.\n\nAn imaging appearance indicative of effective healing is interpreted as a better outcome."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cartilage', 'Damage', 'Chondral defect', 'Chondromalacja', 'Techniques', 'Articular Cartilage Treated', 'Autogenous Transplant', 'PRP GF', 'Hyaluronic Acid', 'Mesenchymal Cells'], 'conditions': ['Osteoarthritis, Knee', 'Chondral Defect', 'Chondromalacia, Left Knee', 'Chondromalacia, Right Knee', 'Articular Cartilage Disorder of Knee']}, 'descriptionModule': {'briefSummary': 'The main objective of the research project is to evaluate the results of the treatment of chondromalacia of the cartilage in the knee joint with the use of: autogenous transplantation of fragmented adipose tissue taken from the abdominal wall - (MyStem, Lipogems, Arthrex).\n\nPRP GF (platelet-rich plasma with growth factors) (Ycellbio, ACP Arthrex, Neoregen, FrankPharma), Mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest - (Harvest, Arthrex), Hyaluronic acid - low molecular weight (Synvisc, Biolevox, ArtiAidPlus), Hyaluronic acid - cross-linked Arti Aid Plus, Synovial, Durolain, StavOn, Collagen - Guna, Orthokine.\n\nThe specific objectives are: to compare the results of treatment of analogous zones of cartilage defects in the knee joint obtained in the study groups using two methods: microfractures and microfractures with simultaneous intra-articular injection of autogenous cartilage graft and PRP GF (Auto Cart-Arthrex method). The results for the operated limb in both groups will be compared both between the groups and with the results of clinical and biomechanical tests for the non-operated limbs.', 'detailedDescription': 'The study will be prospective, randomized. The study groups will consist of 30 people with damage to analogous cartilage zones of the knee joint qualified for arthroscopic treatment.\n\nAfter surgery, patients will be improved according to the same rehabilitation protocol.\n\nThe follow-up examination will include: subjective assessment and clinical examination on day 1, then after 3 and 6 months, MRI imaging, ultrasound after 6 months, biomechanical examination after 3 and 6 months.\n\nA detailed interview will be conducted in the study groups, supplemented with pain assessment on the 1st day after the procedure using the Visual Analogue Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), then with the TAS activity level scale (TAS). Tegner Activity Level Scale), three parts of the 2000 International Knee Documentation Committee (2000 IKDC) questionnaire: Demographic Form, Current Health Assessment Form, percentage of drugs used acute treatment initiation, withdrawal rates due to knee pain, knee range of motion, and adverse events.\n\nThe MRI examination will be carried out on a 1.5 Tesla apparatus, the ultrasound examination on a apparatus with the option of elastometry and BMI.\n\nMeasurements of the range of motion of the knee joint, measurements of the circumference of the knee joint and thigh, measurements of the torques of the extensor and flexor muscles of the knee joint as well as the muscles responsible for the internal and external rotation of the lower leg relative to the thigh in the knee joint in static and isokinetic conditions, measurements of proprioception on the Biodex 4 measuring stand System, measurements of gait kinetics and kinematics using the BTS Smart optoelectronic system for three-dimensional movement analysis and two Kistler strain gauge platforms, as well as the squat test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgery for ACL damage to the knee joint;\n* Arthroscopic surgery;\n* No prior knee surgical interventions;\n* No additional pathologies in this anatomical area;\n* Informed consent of the patient to participate in the study.\n\nExclusion Criteria:\n\n* Previous surgical interventions in the examined anatomical area;\n* Additional pathologies in this area identified as part of preoperative diagnostics;\n* Damage to the second knee joint;\n* Failure to comply with the rigor of the same rehabilitation treatment protocol.'}, 'identificationModule': {'nctId': 'NCT07110402', 'briefTitle': 'Evaluation of Treatment of Osteoarthritis of the Knee in the Form of Chondromalacia of the Articular Cartilage Treated in the Arthroscopic Technique With the Use of:Autogenous Transplantation of Fragmented Adipose Tissue,PRP GF,Mesenchymal Cells,Hyaluronic Acid-low Molecular Weight and Cross-linked', 'organization': {'class': 'OTHER', 'fullName': 'eMKa MED Medical Center'}, 'officialTitle': 'Clinical and Comparative Evaluation of Treatment Results for Osteoarthritis of the Knee in the Form of Chondromalacia of the Articular Cartilage Treated in the Arthroscopic Technique With the Use of: Autogenous Transplant of Fragmented Adipose Tissue Taken From Abdominal Integuments, PRP GF (Platelet-rich Plasma With Growth Factors), Mesenchymal Cells Centrifuged From Bone Marrow Cells Taken From the Iliac Crest, Hyaluronic Acid - Low Molecular Weight, Hyaluronic Acid - Cross-linked', 'orgStudyIdInfo': {'id': 'KB-633/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Autogenous transplant of fragmented adipose tissue taken from abdominal integuments', 'description': 'Treatment of chondromalacia of the cartilage in the knee joint with the use of autogenous graft of fragmented adipose tissue taken from the abdominal wall - MyStem, Lipogems, Arthrex.', 'interventionNames': ['Procedure: Autogenous transplant of fragmented adipose tissue taken from abdominal integuments']}, {'type': 'EXPERIMENTAL', 'label': 'PRP GF (platelet-rich plasma with growth factors)', 'description': 'Treatment of chondromalacia of the cartilage in the knee joint with the use of PRP GF (platelet-rich plasma with growth factors: Ycellbio, ACP Arthrex, Neoregen, PhankPharma).', 'interventionNames': ['Procedure: PRP GF (platelet-rich plasma with growth factors)']}, {'type': 'EXPERIMENTAL', 'label': 'Mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest', 'description': 'Treatment of cartilage chondromalacia in the knee joint using mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest - (Harvest, Arthrex),', 'interventionNames': ['Procedure: Mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest']}, {'type': 'EXPERIMENTAL', 'label': 'Hyaluronic acid - low molecular weight', 'description': 'Treatment of chondromalacia of the cartilage in the knee joint with the use of Hyaluronic Acid - low molecular weight (Synvisc, Biolevox, ArtiAidPlus).', 'interventionNames': ['Procedure: Hyaluronic acid - low molecular weight']}, {'type': 'EXPERIMENTAL', 'label': 'Hyaluronic acid - cross-linked', 'description': 'Treatment of chondromalacia of the cartilage in the knee joint with the use of cross-linked Hyaluronic Acid Arti Aid Plus, Synovial, Durolain, StavOn, Collagenu - Guna, Orthokine.', 'interventionNames': ['Procedure: Hyaluronic acid - cross-linked']}], 'interventions': [{'name': 'Autogenous transplant of fragmented adipose tissue taken from abdominal integuments', 'type': 'PROCEDURE', 'description': 'Treatment of chondromalacia of the cartilage in the knee joint by arthroscopic technique with the use of autogenous graft of fragmented adipose tissue taken from the abdominal wall.', 'armGroupLabels': ['Autogenous transplant of fragmented adipose tissue taken from abdominal integuments']}, {'name': 'PRP GF (platelet-rich plasma with growth factors)', 'type': 'PROCEDURE', 'description': 'Treatment of chondromalacia of the cartilage in the knee joint by arthroscopic technique with the use of PRP GF (platelet-rich plasma with growth factors)', 'armGroupLabels': ['PRP GF (platelet-rich plasma with growth factors)']}, {'name': 'Mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest', 'type': 'PROCEDURE', 'description': 'Treatment of cartilage chondromalacia in the knee joint by arthroscopic technique using mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest', 'armGroupLabels': ['Mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest']}, {'name': 'Hyaluronic acid - low molecular weight', 'type': 'PROCEDURE', 'description': 'Treatment of chondromalacia of the cartilage in the knee joint with the use of Hyaluronic Acid - low molecular weight', 'armGroupLabels': ['Hyaluronic acid - low molecular weight']}, {'name': 'Hyaluronic acid - cross-linked', 'type': 'PROCEDURE', 'description': 'Treatment of chondromalacia of the cartilage in the knee joint by arthroscopic technique with the use of cross-linked Hyaluronic Acid Arti Aid Plus, Synovial, Durolain, StavOn, Collagenu', 'armGroupLabels': ['Hyaluronic acid - cross-linked']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53-110', 'city': 'Wroclaw', 'state': 'Dolnośląsk', 'country': 'Poland', 'facility': 'eMKa MED Medical Center', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'eMKa MED Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wroclaw Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}